FDA.reportPublic FDA data

Herbal Cough Drops Original Herb

Manufacturer
Topco Associates LLC | Boston Nutraceutical Science SL | Boston Nutraceutical Production SL
Effective date
2025-03-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:50

Label at a glance#

ProductHerbal Cough Drops Original Herb
Active ingredientMENTHOL
Label structure13 sections

Indications and uses

cough as may occur with a cold ocassional minor irritation and sore throat

Dosage and administration

Adults and children 6 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed or as directed by the doctor Children under 6 years: as a doctor

Label contents#

Full prescribing information#

USES

OTC - PURPOSE SECTION

  • cough as may occur with a cold
  • ocassional minor irritation and sore throat

Menthol

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Menthol 4.8 mg

Stop and Consult a Doctor if

OTC - ASK DOCTOR SECTION

  • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
  • Sore mouth symptons do not improve in 7 days, or if irritation, pain, or redness persists or worsens.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask a health professional before use.

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of chilcren. In case of overdose, get medical help or contact a Poison Control Center right away.

Questions?

OTC - QUESTIONS SECTION

Questions? or to report an adverse event call 1-888-423-0139

When using this product

OTC - WHEN USING SECTION

When using this product

  • do not exceed recomended dosage

Other information

OTHER SAFETY INFORMATION

Other information

  • 10 calories per drop
  • Store in a cool and dry place

Warnings

WARNINGS SECTION

Warnings

Sore throat warning: Severe or persisten sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Back PanelBack PanelElderflower, Horehound, Hyssop, Lemon balm, Linden flowers, Mallow, Peppermint, Sage, Thyme, Wild thyme, Glucose syrup, Sucrose, Caramel color, Natural flavors

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 6 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed or as directed by the doctor
  • Children under 6 years: as a doctor

Indications & Usage Section

Uses temporarily relieves:

  • cough as may occur with a cold
  • ocassional minor irritation and sore throat

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FrontalFrontal

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
637119menthol 4.8 MG Oral LozengePSN1
637119menthol 4.8 MG Oral LozengeSCD1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-061-01Herbal Cough Drops Original Herb45 in 1 BAGPASTILLE451

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-061HERBAL COUGH DROPS ORIGINAL HERB (COUGH DROPS) PASTILLE [TOPCO ASSOCIATES LLC]1Current NDC, 1 package rows20250309_2fb22181-aee3-d0bf-e063-6294a90a7865.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76162-06176162-061-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
SAMBUCUS NIGRA FLOWER07V4DX094TIACT
LEMON BALM OILMJ76269K9SIACT
MENTHOLL7T10EIP3AACTIB
THYMECW657OBU4NIACT
CARAMELT9D99G2B1RIACT
FLAVONES2V45N7G3BIACT
SUCROSEC151H8M554IACT
GLUCOSE5SL0G7R0OKIACT
TILIA CORDATA FLOWERCFN6G1F6YKIACT
MALVA NEGLECTA WHOLES0QQA41760IACT
WILD THYMEKXK6I80R8WIACT
PEPPERMINTV95R5KMY2BIACT
SAGE065C5D077JIACT
HYSSOPUS OFFICINALIS WHOLE0IQW001KPEIACT
HOREHOUNDK08036XEJVIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Herbal Cough Drops Original HerbCOUGH DROPSTopco Associates LLC2fb22181-aee3-d0bf-e063-6294a90a78652025-03-06WarningsExact identifier
ndc (package): 76162-061-01
ndc (product): 76162-061
ndc11 (package): 76162006101
spl id: 2fb220d0-c667-0178-e063-6394a90a7a13
spl set id: 2fb22181-aee3-d0bf-e063-6294a90a7865

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.